Advances In Scar Management

An interview with Tom Fallon

founder and head of product development ReJuveness LLC

Question: What is your view of the landscape of scar management since the founding of ReJuveness. ReJuveness?

Fallon: When we started Rejuveness in 1994 we were one of a few companies marketing silicone sheeting scar management as a prescription device. The alternatives were rather evasive treatments such as steroid injections, radiation , surgical excision and cryotherapy or freezing the scars. At that point keloids were believed to be a deep dermal proliferation disorder involving fibroblast over-production of collagan and the solution was thought to be a destruction of fibroblast in the area. In 1999 a Japanese study showed that problem over-scarring had a compromised stratum corneum across the board. So the problem of the top layer of skin with little integrity was added to a cause of the pathology.The scarring disorders was like an open leison. The most promising advance at year 2000 point came with ReJuveness siliocne free Hyper-Heal cream a stratum corneum barrier repair cream .In -house clinical trials reflected improved results for keloids, problem scar prevention and more scarless like healing. These results were obtained in a shorter order. With the addition of our new ReJuveness Hyper-Heal scar conditioner, severe keloids were flattened and brought back to normal color within a month. One month’s time is a substantial improvement in treatment time over what it would take ReJuveness® Silicone Sheeting by itself which is estimated at three months to resolve the same type of scar.

Question: So that is year 2000-what has happened since then in the scar management field in general?

Fallon: First there was a push in the research community what was actually happening that silicone sheeting was the only bio-material that held resolve these scars. The use of lasers in scar mangement started to rise.

Fallon: At ReJuveness we remain convinced that the prevention and resolution of problem scars revolves around the noninvasive application of silicone sheeting. Theoretically, it seems as if silicone sheeting may be serving a host of therapeutic functions simultaneously. Theories of a singular mechanism of action for silicone – be it occlusion, hydration, static electricity or pressure have proven inadequate. More convincing theories are emerging surrounding barrier function recovery and healing initiated by the synergistic balance of calcium and potassium and lipids. It is believed that silicone sheeting plays a major role in maintaining this synergistic balance.

Question: Can you offer any theoretical explanations to explain the significant decrease in treatment time you achieved in these clinical trials?

Fallon: The present advance in scar management has a twofold explanation: 1. Silicone sheeting is acting as a sponge. Through absorption, it promotes a synergistic balance of calcium-potassium that reestablishes the stratum corneum or the outside layer of the skin as an acidic mantle. 2. The successful transdermal penetration of essential fatty acids into the stratum corneum of the lipid deficient keloids and hypertrophic scars. The successful topical application of lipids initiates proper signal transduction to fibroblast. The almost tenfold improvement in treatment time with ReJuveness Hyper-Heal cream is simply due to the simultaneous replenishment of essential fatty acids into a receptive dermal environment. An unreceptive dermal environment for essential fatty acids is one with an excessive and improper balance of potassium and calcium. The body does not synthesize essential fatty acids by itself. Until recently, it was thought they could only be supplied into the dermis through diet. Topical application just ineffectively lay on top of the skin. With the transdermal technology in ReJuveness Hyper-Heal scar cream, topical application of essential fatty acids is now possible. The rapid resolution of barrier recovery, as well as the reestablishment of the signal transduction provided by the ceramides and other lipids, enables the resolution of these scars in one tenth the time.

Question: These theoretical explanations seem a radical departure from traditional theories of keloidal and hypertrophic scarring. What is your understanding of the etiology of these pathological scars?

Fallon: The over-proliferation of scar tissue characteristic of problem scarring would make it appear as if this pathological scarring was purely a post-wound phenomenon. So it came as a surprise to most researchers in the field when Sutake et al published some measurements which corresponded over scarring with early superficial wound phenomena such as open blisters or resurfaced skin. Levels nearly four times higher were measured in keloids and hypertrophic scars compared to normal scars and skin in the categories of: 1. Transepidermal water vapor loss 2. Electric conductivity 3. Stratum corneum turnover rate Only after these results were reported was it fully realized that hypertrophic scars and keloids could probably more accurately be described as unhealed lesions. Our own clinical results concur with leading researchers that these common measurements between problem scarring and open blister wounds suggest a common resolution in barrier recovery. Our new protocols utilize nutritional methods initiating healing cascades originating in the recovery of barrier function in the stratum corneum.

Question: How do nutritional imbalances in the epidermis cause problem scarring?

Fallon: Scar formation can be looked at as a process of alternating cell production and cell death (apoptosis) at the end of the wound healing cascade. Where a healthy transformation is when a scar goes from a bumpy red mass to a thin white line, hypertrophic scars and keloids remain at the early stage. Hypertrophic and keloid scars are ones that don’t reach that point because the proper biological signals cell production and cell death are terminated and they never reach the fibroblast within the realms of the lesion to tell them to stop producing scar tissue nor are the signals for cell apoptosis initiated.

Although after tape stripping 50% improvement in barrier function occurs within the first six hours and by 24-36 hours barrier function returns to normal, barrier recovery can take months using silicone sheeting alone, after which resolution of the exaggerated scarring occurs rather suddenly.

Barrier recovery is thought to be induced by several different mechanisms. Evidence is pointing towards calcium and potassium balance in the stratum corneum as important in the resolution of over scarring. Through mostly unpublished work having case it has been demonstrated that silicone sheeting absorbs calcium and potassium from the stratum corneum which is thought to reestablish the acidic mantle that leads to barrier function normalization.